510(k) K250085
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System by
ACON Laboratories, Inc.
— Product Code NBW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2025
- Date Received
- January 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type